Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Endo Pharmaceuticals |
---|---|
Information provided by: | Endo Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00801398 |
When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity score greater than or equal to 40).
Condition | Intervention | Phase |
---|---|---|
Postoperative Pain |
Drug: Oxymorphone IR |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Ascending, Two-Part, Single- and Multiple-Dose Evaluation of the Safety, Pharmacokinetics, and Effectiveness of Oxymorphone for Acute Postoperatiave Pain in Pediatric Subjects |
Estimated Enrollment: | 48 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Oxymorphone IR: Experimental
Open-Label, 2 part ascending-dose multicenter study
|
Drug: Oxymorphone IR
Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs
|
Ages Eligible for Study: | 12 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Virginia Marinelli | marinelli.virginia@endo.com |
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States | |
United States, District of Columbia | |
Children's Research Institute | |
Washington, District of Columbia, United States | |
United States, Indiana | |
Indiana University School of Medicine | |
Indianapolis, Indiana, United States | |
United States, Texas | |
University of Texas Southwestern Medical Center at Dallas | |
Dallas, Texas, United States |
Study Director: | Harry Ahdieh, Ph.D. | Endo Pharmaceuticals |
Responsible Party: | Endo Pharmaceuticals Inc. ( Sr. Director, CR&D ) |
Study ID Numbers: | EN3203-010 |
Study First Received: | December 2, 2008 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00801398 |
Health Authority: | United States: Food and Drug Administration |
Opioid tolerant Pediatric Pain Non malignant Malignant |
Signs and Symptoms Postoperative Complications Pain Pain, Postoperative Oxymorphone |
Adjuvants, Anesthesia Pathologic Processes Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants |
Narcotics Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions Analgesics, Opioid |